Sepsis and Thiol-Disulfide Balance in Emergency Department

NCT07134868 | Completed

• 1 other identifier: SAU-ED-MA-01
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study was to determine the effectiveness of thiol-disulfide homeostasis in predicting diagnosis and mortality in sepsis patients, and to compare it with other inflammatory markers.

Conditions

Sepsis; Oxidative Stress

Keywords

Diagnostic efficacy; Sepsis; Oxidative Stress; Emergency Department; Thiol- Disulfide Homeostasis

Outcome Measures

Primary Outcomes (1)

• Diagnostic value of serum thiol-disulfide homeostasis parameters in sepsis

  Measurement of serum total thiol, native thiol, disulfide, reduced thiol, and oxidized thiol levels in patients with sepsis and healthy controls at the time of admission, and comparison between groups to evaluate diagnostic performance.

  2 monhts

Secondary Outcomes (2)

• General Characteristics of All Participants

  1 week

• Correlation of inflammatory and biochemical markers with thiol-disulfide homeostasis in sepsis

  10 days

Study Arms (2)

Sepsis Group

ACTIVE COMPARATOR

Consisted of patients diagnosed with sepsis (defined as those presenting to the emergency department with suspected infection and scoring two or higher on the quick Sequential Organ Failure Assessment scoring system according to the Sepsis-3 guidelines) and who agreed to participate in the study.

Diagnostic Test: Thiol- Disulfide Blood Sample Measurement

Control Group

NO INTERVENTION

Comprised of healthy volunteers who presented to the emergency department for any reason and agreed to participate in the study.

Interventions

Thiol- Disulfide Blood Sample Measurement DIAGNOSTIC_TEST

Measurement of thiol-disulfide homeostasis parameters and inflammatory markers from serum samples.

Sepsis Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients aged 18 and above who met the diagnostic criteria were included in the study

You may not qualify if:

• Who did not meet the criteria for sepsis diagnosis according to the quick Sequential Organ Failure Assessment score
• Individuals with malignancy, acute coronary syndrome, acute cerebrovascular event, acute/chronic kidney/liver failure, rheumatologic diseases, febrile neutropenia, immunosuppressive disorders, corticosteroid use, and those
• Individuals with a history of antibiotic use within the last week

Sponsors & Collaborators

• Sakarya University: lead

Study Sites (1)

Sakarya University

Sakarya, Adapazarı, 54050, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Sepsis; Emergencies

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Disease Attributes

Study Officials

• Mehmet Alacam, M.D.

  Sakarya University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medicine Doctor

Study Record Dates

• First Submitted: June 27, 2024
• First Posted: August 21, 2025
• Study Start: June 15, 2018
• Primary Completion: September 30, 2018
• Study Completion: December 15, 2018
• Last Updated: August 21, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)